Coronary CT Angiography for Improved Assessment of Suspected Acute Coronary Syndrome With Inconclusive Diagnostic Work-up
试验速览
- 阶段
- 不适用
- 入组人数
- 230
- 试验地点
- 3
- 主要终点
- Diagnostic accuracy of coronary CT angiography to identify patients with NSTE-ACS.
研究概览
简要总结
Current evaluation of patients suspected of non-ST-elevation acute coronary syndrome is greatly dictated by the results of high-sensitivity troponins. In a substantial number of patients this approach does not provide a conclusive work-up. Patients typically present with slightly elevated high-sensitivity troponins without significant changes during serial sampling and no other clinical clues that can aid in determining the etiology of their chest pain complaints. Uncertainty remains about the optimal diagnostic management of these patients and they are often admitted to undergo invasive angiography. Coronary CT angiography can improve efficiency of clinical care in these patients by reducing unnecessary hospital admissions and invasive angiography. In this study, the investigators will investigate whether a diagnostic strategy comprising of early coronary CT angiography is more clinically efficient than standard optimal care in patients with an inconclusive work-up for non-ST-elevation acute coronary syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting to the emergency department with symptoms suggestive of NSTE-ACS. They do not fulfil criteria for either "rule-in" or "rule-out" NSTE-ACS based on serial sampling of high-sensitivity troponins and standard clinical work-up.
排除标准
- •Inability or unwillingness to provide informed consent.
- •History of proven CAD, defined as documented prior myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft surgery.
- •Previous examination with either invasive angiography or CCTA in the last 3 years.
- •Clinical instability: clinical heart failure, hemodynamic instability, severe chest pain.
- •CCTA-specific contra-indications:
- •Allergy to iodine contrast media
- •Pregnancy
- •Impaired renal function: estimated glomerular filtering rate <60% of the age-corrected normal values
- •Severe arrhythmia likely to affect image interpretation
- •BMI > 40
- •Inability to cooperate during the examination.
结局指标
主要结局
Diagnostic accuracy of coronary CT angiography to identify patients with NSTE-ACS.
时间窗: 30 day
Sensitivity and specificity of coronary CT angiography for the diagnosis of NSTE-ACS.
次要结局
- Potential improvement of diagnostic accuracy with FFR-CT.(30 day)
- Clinical characteristics of no obstructive coronary artery disease on CT.(30 day)
研究者
Admir Dedic
Principal Investigator
Erasmus Medical Center